510(k) K012624
- Device
- REPROCESSED ARTHROSCOPIC BLADES, ARTHROSCOPIC SHAVERS, SHAVER BLADE, BLADE, LIMITED REUSE BLADE, ARTHROSCOPIC BURS
- Applicant
- MEDICAL INSTRUMENTS TECHNOLOGY, INC.
- 510(k) number
- K012624
- Product code
- HRX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-11-08
- Date received
- 2001-08-13
- Regulation
- 888.1100
- Classification name
- Arthroscope
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JACK SPEER
- Address
- 385 N. 3050 E. St. George UT US 84790 84790
FDA Registration Numbers#
- 1222997
- 2245304
- 3003678543
- 3015316279
- 3004215117
- 3014725904
- 3032391
- 3008215723
- 3010432890
- 9613793
- 3005083075
- 2951215
- 3015173212
- 2522206
- 3015453963
- 1724474
- 3004519921
- 3033589330
- 9617616
- 3027339877
- 3010220595
- 3004142400
- 3010280860
- 3011163668
- 3008058135
- 9680001
- 9681574
- 3013023255
- 9680515
- 3017396949
- 1526439
- 3009702671
- 3003755939
- 3006946348
- 3010032903
- 1720929
- 3006891611
- 3006946276
- 1123169
- 2032830
- 1526611
- 3013557562
- 3016099036
- 1416980
- 3002579136
- 3014202166
- 3009746061
- 3014023545
- 3014644276
- 3035366890
- 3008044552
- 3021226419
- 3005977257
- 3021336182
- 9615782
- 3021566676
- 8040510
- 3010155661
- 1721504
- 3024788684
- 3008494403
- 3006950086
- 9680340
- 9680721
- 3017406274
- 9611102
- 3001239363
- 1320894
- 3008837339
- 2650143
- 2528981
- 2081135
- 3007495879
- 3030446844
- 3018094310
- 1643817
- 3008812560
- 3017196117
- 1526534
Source Documents#
Other 510(k) Records For Product Code HRX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252790 | Digital ClarusScope System and Digital NeuroPEN System | Clarus Medical, LLC | 2026-05-26 |
| K253523 | Freedom DS™ Decompression System | Spinal Simplicity | 2026-04-16 |
| K252546 | VantageTM Lumbar Decompression Kit | Allevion Medical, LLC | 2026-03-12 |
| K253217 | MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700) | Medimaging Integrated Solution, Inc (Miis) | 2025-12-23 |
| K250795 | PUREVUE™ FMS | W.O.M. World of Medicine GmbH | 2025-12-05 |
| K252666 | Articulator Arthroscopic Bur | Joint Preservation Innovations, LLC | 2025-11-21 |
| K252458 | Kyphoplasty Balloon Dilatation Catheters | Shanghai Lange Medtech Co., Ltd. | 2025-11-03 |
| K252020 | TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly | Hand Biomechanics Lab, Inc. | 2025-10-15 |
| K252594 | UltraGuideCTR® image guided soft tissue release system | Sonex Health | 2025-09-29 |
| K243774 | ELID (Endoscopic Less Invasive Decompression) System | Lesspine Innovations | 2025-08-27 |
| K241990 | SpineSite Endoscope System | Hydrocision, Inc. | 2025-07-30 |
| K243602 | Arthrex Spine Endoscope | Arthrex, Inc. | 2025-05-16 |
| K242417 | VECTR – Video Endoscopic Carpal Tunnel Release System | Rafael Medical Devices, LLC | 2024-12-11 |
| K243020 | MIDASVu | Intravu, Inc. | 2024-12-02 |
| K233800 | Vertos mild Device Kit (MDK-0002) | Vertos Medical, Inc. | 2024-05-06 |
Legacy Summary#
summary
FDA Review#
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